Olympus Creatinine Reagent

FDA 510(k) K923526 · Olympus Corp.

Substantially Equivalent

510(k) numberK923526

Submission

Device name
Olympus Creatinine Reagent
Applicant
Olympus Corp.
Lake Success, NY, US
Received
July 16, 1992
Decision date
September 18, 1992
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
CGX – Alkaline Picrate, Colorimetry, Creatinine
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1225
Specialty
Clinical Chemistry

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Questions and answers

When was Olympus Creatinine Reagent cleared by the FDA?

Olympus Creatinine Reagent (K923526) received a 510(k) decision of Substantially Equivalent on September 18, 1992, 64 days after the submission was received.

What is the product code of K923526?

The FDA product code is CGX – Alkaline Picrate, Colorimetry, Creatinine, a Class II (moderate risk) device regulated under 21 CFR 862.1225.